The EU's open strategic autonomy in the field of pharmaceuticals: overcoming import dependencies for antibiotics through the EU authority HERA

The COVID-19 pandemic and war in Ukraine have highlighted the dependence of the European Union (EU) on individual trading partners. One of the tasks of the European Commission's new Directorate-General, the Health Emergency Preparedness and Response Authority (HERA), established in 2021, will therefore be to contribute to the EU's "open strategic autonomy" by identifying and eliminating import dependencies in the field of pharmaceuticals. HERA's work thus aligns with current EU efforts to reduce concentrated import risks. Here, three aspects of this work are particularly important: the identification of dependencies, the development of strategies to over­come them and the incorporation of these strategies within global health governance. (author's abstract

IRISS (Increasing Resilience in Surveillance Societies) FP7 European Research Project, Deliverable D6.1: Civil Protection in a European Context, in A report on resilience in "democratic" surveillance societies. Civil protection in a European context, in A report on resilience in "democratic" surveillance societies

The term "civil protection" has different meanings and interpretations, sometimes varying from country to country. In the context of Europe, civil protection and its developing and multi-faceted relationship with resilience is a relatively recent phenomenon, arguably originating from the end of the cold war, commonly described as the period from the end of World War II to the early to mid-1990s, when the focus changed to civil protection from civil defence, with contingency plans being put in place by many countries for the civilian populations to organise, prepare to mobilise and defend themselves in the event of a major incident such as a nuclear attack or potential invasion by another country. Over the past two to three decades, and at the level of the European Union, the use of the term "civil protection" has become synonymous with the contingency and emergency planning arrangements that countries either individually and now increasingly collectively (such as the six regional European civil protection initiatives) have put in place to increase resilience and the ability to respond effectively both to the threat or occurrence of natural disasters, such as earthquakes and damage to the built environment, volcanic eruptions, forest fires, floods, landslides and man-made disasters such as marine pollution incidents or threats or actual acts of terrorism such as those experienced in London (2005) or Madrid (2004). . The European Union determined that increasing preparedness and resilience to natural or man-made disasters or to terrorism events would require greater humanitarian focus and co-ordination of resources at a community-based level. In response to this, the European Union adopted two pieces of legislation which cover European civil protection: first, Council Decision 2007/779/EC established a Community Civil Protection Mechanism and, second, Council Decision 2007/162/EC established a Civil Protection Financial Instrument. The Mechanism covers the response and some preparedness activities, while the Instrument enables actions in the three key areas of prevention, preparedness and response

Translating EU civil protection in the Nordic states – towards a theoretical understanding of the creation of European crisis management capacities.

This paper analyses how EU civil protection is translated (both in a linguistic/conceptual sense and in an organisational sense) in the Nordic states. The analysis builds on interviews with civil servants and illustrates how European crisis management capacities are created. Doing so it also contributes to the debate about Europeanization and how it can be studied. The paper shows that the creation of European crisis management capacities (in a wide sense) leads to Europeanization, which involves a translation process where linguistic/conceptual translation and organisational change are intertwined, and where differing national traditions affect the process

Chronicle of a Pandemic Foretold. CEPS Policy Insights No 2020-05 / March 2020

In just a few weeks, COVID-19 appeared in China and quickly spread to the rest of the world, including Europe and the United States. Many have rushed to describe the outbreak as a ‘black swan’ – an unpredictable event with extremely severe consequences. However, COVID-19 was not only predictable ex post: it was amply predicted ex ante. This allows us to draw some preliminary lessons: • First, economic policy will need to shift from its current focus on efficiency, towards a greater emphasis on resilience and sustainability. • Second, a more centralised governance to address health emergencies is needed. • Third, Europe should create a centre for the prevention of large-scale risks. • Fourth, digital technologies, if handled with care, can be an important part of both a mitigation and a response strategy. • Fifth, Europe should improve its science advice and communication functions. Finally, there are many ways to pursue enhanced resilience and responsiveness, but not all of them are compatible with sustainability and democratic values. The challenge is to find an adequate policy mix, which safeguards individual rights and liberties, protects the economy, and at the same time strengthens government preparedness for cases of epidemics and pandemics

Preparedness, crisis management and policy change : EMU at the critical juncture of 2008-2013

Focusing on the role of the European Central Bank during the recent banking and sovereign debt crisis in the euro area, this article contributes to the literature on ideational and institu-tional change at critical junctures. In line with recent calls to take the temporal dimension of political change seriously, the article argues that in the context of explosive economic crises a phase of emergency crisis management precedes the phase of purposeful institution building. What happens during this phase is crucial, for in spite of their improvised charac-ter emergency crisis management measures create their own path dependencies. This, how-ever, raises the question of why crisis managers act the way they do. While it is true that crisis managers act as bricoleurs who use whichever tools they find at their disposal, the question of why certain tools are available rather than others calls for a historicisation of crisis management. The article therefore introduces the variable of preparedness, which measures the extent to which the pre-crisis policy paradigm was prepared for the occur-rence of, in this case, the combination of a systemic banking crisis and a sovereign debt cri-sis. The empirical section then compares pre-crisis contingency planning and in-crisis contingency acting, revealing several inconsistencies in the pre-crisis crisis paradigm. The analysis matters for our understanding of political change because these inconsistencies caused the ECB to assume a dominant position in the euro area during the emergency phase of the crisis. This windfall gain in power for the ECB has already begun to shape the future ideational and institutional order of the euro area

Pandemic influenza control in Europe and the constraints resulting from incoherent public health laws

© 2010 Martin et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Background: With the emergence of influenza H1N1v the world is facing its first 21st century global pandemic. Severe Acute Respiratory Syndrome (SARS) and avian influenza H5N1 prompted development of pandemic preparedness plans. National systems of public health law are essential for public health stewardship and for the implementation of public health policy[1]. International coherence will contribute to effective regional and global responses. However little research has been undertaken on how law works as a tool for disease control in Europe. With co-funding from the European Union, we investigated the extent to which laws across Europe support or constrain pandemic preparedness planning, and whether national differences are likely to constrain control efforts. Methods: We undertook a survey of national public health laws across 32 European states using a questionnaire designed around a disease scenario based on pandemic influenza. Questionnaire results were reviewed in workshops, analysing how differences between national laws might support or hinder regional responses to pandemic influenza. Respondents examined the impact of national laws on the movements of information, goods, services and people across borders in a time of pandemic, the capacity for surveillance, case detection, case management and community control, the deployment of strategies of prevention, containment, mitigation and recovery and the identification of commonalities and disconnects across states. Results: Results of this study show differences across Europe in the extent to which national pandemic policy and pandemic plans have been integrated with public health laws. We found significant differences in legislation and in the legitimacy of strategic plans. States differ in the range and the nature of intervention measures authorized by law, the extent to which borders could be closed to movement of persons and goods during a pandemic, and access to healthcare of non-resident persons. Some states propose use of emergency powers that might potentially override human rights protections while other states propose to limit interventions to those authorized by public health laws. Conclusion: These differences could create problems for European strategies if an evolving influenza pandemic results in more serious public health challenges or, indeed, if a novel disease other than influenza emerges with pandemic potential. There is insufficient understanding across Europe of the role and importance of law in pandemic planning. States need to build capacity in public health law to support disease prevention and control policies. Our research suggests that states would welcome further guidance from the EU on management of a pandemic, and guidance to assist in greater commonality of legal approaches across states.Peer reviewe

The Global Health Law Trilogy: Towards a Safer, Healthier, and Fairer World

Global health advocates often turn to medicine and science for solutions to enduring health risks, but law is also a powerful tool. No state acting alone can ward off health threats that span borders, requiring international solutions. A trilogy of global health law—the WHO Framework Convention on Tobacco Control, International Health Regulations (2005), and Pandemic Influenza Preparedness Framework—strives for a safer, healthier, and fairer world. This article critically reviews this global health law trilogy. These international agreements are not well understood, and contain gaps in scope and enforceability. Moreover, major health concerns remain largely unregulated at the international level, such as non-communicable diseases, mental health, and injuries. The article promotes the lessons learned from 21st century international health law, which are that broad scope, robust compliance, inclusion of public and private actors, and sustainable financing are essential to success. It further explores the notion that in an age of nationalistic populism, collective action remains vital to ameliorate globalized health threats, helping realize the right to health. Reforms to the “trilogy” of global health laws are necessary to assure success and provide a critical roadmap for the World Health Organization’s next Director-General. The article concludes by calling on the new WHO D-G to take additional action toward a safer, healthier and fairer world by pushing for novel global health laws on major health hazards, including noncommunicable diseases, mental health and injuries, and new initiatives such as universal health care

Key dimensions for the prevention and control of communicable diseases in institutional settings. a scoping review to guide the development of a tool to strengthen preparedness at migrant holding centres in the EU/EEA

Migrant centres, as other institutions hosting closed or semi-open communities, may face specific challenges in preventing and controlling communicable disease transmission, particularly during times of large sudden influx. However, there is dearth of evidence on how to prioritise investments in aspects such as human resources, medicines and vaccines, sanitation and disinfection, and physical infrastructures to prevent/control communicable disease outbreaks. We analysed frequent drivers of communicable disease transmission/issues for outbreak management in institutions hosting closed or semi-open communities, including migrant centres, and reviewed existing assessment tools to guide the development of a European Centre for Disease Prevention and Control (ECDC) checklist tool to strengthen preparedness against communicable disease outbreaks in migrant centres. Among articles/reports focusing specifically on migrant centres, outbreaks through multiple types of disease transmission were described as possible/occurred. Human resources and physical infrastructure were the dimensions most frequently identified as crucial for preventing and mitigating outbreaks. This review also recognised a lack of common agreed standards to guide and assess preparedness activities in migrant centres, thereby underscoring the need for a capacity-oriented ECDC preparedness checklist tool